Kornimate/medical-research-clean huggingface dataset:
clinical, electrophysiological and e-field modelling evidence of high density transcranial direct current stimulation in motor stroke

Conditions: Stroke

Summary: the present study aims to investigate the therapeutic potential of a high definition transcranial direct current stimulation protocol, stimulating frontal and cerebellar areas boosting the cognitive and motor recovery of stroke population.

stroke cause direct network dysfunctions correlating with the underlying behavioral deficits in that context, characterize and boost neuronal reshaping towards a favorable state for recovery has become a distinguished therapeutic approach. transcranial direct current stimulation (tdcs) is a non-invasive brain stimulation able to locally modulate neuronal activity and modify neural arquitecture. in such scenario, the investigators develop in this protocol a new tdcs multitarget fronto-cerebellar tdcs approach, exploring the benefits of boosting motor dysfunctions by means of a dual site-approach, up-regulating dlpfc and cb activity. the investigators here design a pilot experimental clinical trial exploring the accumulative clinical potential for motor skill \& learning recovery and eeg effects of a high-density bifocal transcranial direct current stimulation protocol (hd-tdcs). the investigators hypothesize that the tdcs protocol will promote direct functional motor reorganization helping relearning motor process, will boost the activity of prefrontal settled systems correcting attentional deficits and increasing strength connectivity with premotor systems, and will normalize large-scale abnormalities increasing interhemispheric functional connectivity (i.e., functional integration), decreasing interhemispheric asymmetry (i.e., functional segregation) and restoring transcallosal balance, impacting positively either in motor and cognitive recovery. all in all, this study will be the first exploring the simultaneous modulation of two different targets in stroke population corresponding to different networks looking for a summative/synergistic effects helping motor and cognitive functions recovery.

Eligibility criteria:
inclusion criteria: * received a diagnosis of supratentorial ischemic or hemorrhagic stroke confirmed by neuroimage (mri, pet, ct, fmri or dti) in the middle cerebral artery territory or encompassing fronto-temporo-parietal hemorrhages * enrolled in a live rehabilitation program in the rehabilitation and physical medicine department * between 4 and 12 months after stroke episode * have signed the informed form exclusion criteria: * medical instability with the presence of infections, assisted ventilation, epilepsy or recurrent seizures, untreated psychiatric disorders or an active treatment with sedative drugs * tdcs contraindications as defined by the international safety guidelines * large aphasic, psychiatric and cognitive deficits limiting patient's comprehension

Keywords: stroke neuromodulation transcranial direct current stimulation non-invasive brain stimulation
effects of administration of fostamatinib on blood concentrations of rifampicin in healthy subjects.

Conditions: Rheumatoid Arthritis; Healthy Volunteers

Summary: the purpose of this study is to investigate the drug interaction between fostamatinib and rifampicin by comparing the safety, tolerability and plasma concentration of fostamatinib when administered alone and with rifampicin in healthy subjects


Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study specific procedures * males or females aged 18 to 55 years (inclusive) * minimum weight of 50 kg and a body mass index (bmi) of 18 to 35 kg/m2 (inclusive) * female subjects must have a negative pregnancy test at screening and admission of each treatment period, must not be lactating, and must be of non-childbearing potential exclusion criteria: * history or presence of gastrointestinal, hepatic or renal disease (except for cholecystectomy) * any clinically significant illness, medical or surgical procedure, or trauma within 4 weeks before period 1 day 1 * subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day * absolute neutrophil count of less than 2500/mm3 or 2.5 x 109/l * any previous treatment with fostamatinib

Keywords: phase 1 healthy volunteers rheumatoid arthritis ra fostamatinib rifampicin drug-drug interaction pharmacokinetics amount of rifampicin in blood
phase i clinical study to evaluate the safety and efficacy of rgb-5088 in patients with type 1 diabetes mellitus

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus

Summary: this phase i clinical trial is a single-center, single-arm, open-label study aimed at evaluating the safety and therapeutic efficacy of rgb-5088 islet cell transplantation in patients with type 1 diabetes mellitus.


Eligibility criteria:
key inclusion criteria: * age: 18-60 years old (including 18 and 60 years old), male and female; * type 1 diabetes patients (including those who have received organ transplantation such as liver and kidney); * stimulated c-peptide \< 0.3 ng/ml; * the patient had at least one severe hypoglycemia within 12 months before being included in the project key exclusion criteria: * type 2 diabetes patients; * untreated proliferative diabetes retinopathy; * serious heart disease; * serious gastrointestinal dysfunction ； * serious psychological diseases； * any history of malignancy; * have a history of tobacco, alcohol and drug abuse; * for female subjects: pregnancy test positive, lactation or unwilling to use effective contraceptive measures during the study period, male patients: intent to procreate or unwilling to use effective contraceptive measures during the study period.
influence of co-vid 19 pandemic on screening mammography single institution

Conditions: COVID-19; Breast Cancer

Summary: to assess whether the covid-19 pandemic delayed breast cancer diagnosis in taiwan, an asian country with a low covid-19 incidence.

the institutional review board approved this retrospective study at a public academic medical center. the monthly volume of breast biopsies and breast cancers during the covid-19 pandemic (between january 1 and july 31, 2020) was compared to the same period a year earlier (pre-covid-19).

Eligibility criteria:
inclusion criteria: * receiving breast exam 2019-2020 exclusion criteria: * lost clinical follow-up

Keywords: covid-19 breast cancer
culturally relevant exercise for diabetes (cure-d)

Conditions: Diabetes Mellitus

Summary: the culturally relevant exercise for diabetes (cure-d) study will determine whether a culturally-sensitive dance intervention is an accepted and effective physical intervention for south asian women with type 2 diabetes mellitus. the cure-d study will determine if bollywood dance exercise improves diabetes outcomes in south asian women.


Eligibility criteria:
inclusion criteria: * sex: females * ethnicity: south asian * hemoglobin a1c ≥ 6.0 mg/dl * a pamf patient for ≥ 24 months * able and willing to enroll and meet the requirements of the study. exclusion criteria: * bmi \> 35 * insulin dependent * current atrial fibrillation * active treatment for cancer * diagnosis of a terminal illness and/or in hospice care * any serious medical condition which would prevent long-term participation or which would contraindicate physical activity * pregnant, lactating, or planning to become pregnant during the study period * inability to speak, read, or understand english * no longer a pamf patient or planning to transfer care outside of pamf during the study period * investigator discretion for clinical safety or protocol adherence reasons.

Keywords: south asian
epigenetic and genetic effects in cancer patients: analysis pre and after treatment

Conditions: Male Infertility; Cancer; Epigenetic Disorder

Summary: the prognosis in cancer patients has improved over the years. survivor rates have increased significantly, and paternity has become an important concern in more than 50% of young male survivors. sperm cryopreservation before cancer treatment is highly recommendable in these patients, as a strategy to preserve their fertility due to is not possible to predict how the chemo or radiotherapy treatment will affect the spermatogenesis. the objective of this study is to evaluate if sperm after an antineoplastic treatment can be safely used. to determine the possible effects of oncological treatments in the spermatogenesis, three parameters will be analyzed, aneuploidy frequencies, dna fragmentation in single and double-strand breaks and methylation levels to determine epigenetic changes before and after the therapy. if cancer treatment affect sperm genetic integrity, it would have a clinical impact in the offspring of these patients. identify the different side effects of antineoplastic treatments in dna sperm will provide a clinical improvement in order to select the best sperm sample in an ivf treatment and it will facilitate genetic counseling


Eligibility criteria:
inclusion criteria: patients with previous history of cancer patients with several sperm samples cryopreserved to be able to thaw a part without damaging their future options, in case they need them. patients treated with chemotherapy and/or radiotherapy patients have finished their oncological treatment. patints recovered spermatogenesis after the oncological treatment to be able to obtain a sperm sample. exclusion criteria: patients with only one sperm sample cryopreserved patients that are not be able to obtain a fresh sample post treatment patients with less than 3 million sperm per milliliter

Keywords: sperm dna fragmentation sperm epigenetics testicular cancer
increasing influenza and tdap vaccination of pregnant women

Conditions: Immunization; Infection; Pregnancy Related

Summary: pregnant women who get influenza are more likely than non-pregnant women to have serious complications, including hospitalizations, death, preterm labor and premature birth. pertussis can cause hospitalization or death for newborns. however, influenza and tdap vaccination rates for pregnant women are low nationally. in this study, the investigators will perform a randomized controlled trial aimed at practice change in obstetricians' offices, with an overall goal of reducing morbidity and mortality from influenza and pertussis infections.

infants under 6 months of age at increased risk of both influenza (flu) and pertussis disease, and pregnant women risk serious illness and premature labor from flu. the advisory committee on immunization practices recommends that women receive a flu vaccine in flu season, and tetanus toxoid, reduced diphtheria toxoid, acellular pertussis (tdap) vaccine during each pregnancy (ideally between 27-36 weeks) to lower the risk for flu and pertussis disease for themselves and their infants. however, only half of pregnant women in the us receive a flu and tdap vaccine, respectively; only 33% of women receive both vaccines. lack of vaccination stems from a combination of patient (lack of knowledge, vaccine hesitancy), provider (suboptimal communication skills, missed opportunities), and system (e.g. lack of standing orders and patient reminders) factors. an effective intervention is needed to improve flu and tdap vaccination rates for pregnant women. to address these low vaccination rates the investigators plan to use a clustered rct (randomizing practices), allocating half of the participating practice sites within each health system to the vax-mom intervention and the other half to standard of care. the multi-component vax-mom intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates.

Eligibility criteria:
inclusion criteria: patients * sex is female * pregnant * identified as being eligible for influenza or tdap vaccine providers * any provider, nurse or staff associated with the participating sites exclusion criteria: patients * none providers * none

Keywords: pertussis influenza vaccination prenatal care
thermal imaging in old and frail in the community

Conditions: Old Age; Debility

Summary: this study aims to test whether infrared thermal imaging using a non-touch, non-ionising, thermal camera system is feasible and reliable as an independent technique for thermal comfort assessment in older people and frail older people living in a care home and with or without mild cognitive impairment.

thermal comfort (tc) is a complex interaction involving physiological, social, cultural and clothing factors. in hospital and in care homes, health-issues (frailty, dementia, immobility) can affect a person's perception of tc. in the uk 18,000 care homes provide living-communities for approximately 400,000 people. many are old/frail and vulnerable to indoor chilling. a quality indicator for a good ''home'' environment is related to tc. however, in multiplyoccupied rooms tc varies between individuals. the challenge in health-assessment is in identifying ''uncomfortable'' residents (too hot/too cold). as tc is a subjective perception; a carer cannot reliably predict tc in another person. the objectives are to use infra-red thermal imaging (irti) to 'see' the body temperature map, to demonstrate prevalence of tc/thermal discomfort, to demonstrate whether there is correspondence/dissociation between tc self-report and irti-measured body/extremity (hand) temperature. the study aims to establish if tc can be predicted by an independent non-invasive imaging device expected achievements are a two-way pathway to health impact: 1. identification of eligible adults via nhs intermediary care- and awaiting care home residency 2. expert guidance and collaboration with nhs partners 3. translation of results from community to nhs setting e.g. stoke/aged care medicine for improved thermal care on the hospital wards longer-term the expected achievement (5-7 years)-working with nhs colleagues and design/product development teams is expected to lead towards a commercialisation pathway.

Eligibility criteria:
inclusion criteria: care home residents who are: * aged over 60 to a maximum age of 105 years * able to sit comfortably for up to 20 minutes without marked agitation. * ability to understand, read and speak english. exclusion criteria: care home residents who are/have: * severe dementia * unable to hold a conversation * who do not wish to take part in the study * unable to speak or understand english * unable to sit with other residents * who are severely agitated or unsettled

Keywords: thermal comfort
evaluation of nutritional prevention program for women's cardiovascular health on quality of life (safe)

Conditions: Healthy Volunteers

Summary: the objective is to evaluate the effect of a nutritional prevention program associated with the consumption of "primevère margarine" on the quality of life of women at risk of cardiovascular disease after 10 group coaching sessions in nutrition and physical activity.

the objective is to evaluate the effect of a nutritional prevention program associated with the consumption of "primevère margarine" on the quality of life of women aged 40 to 65 with cardiovascular risk 3 months after 10 group coaching sessions. the nutritional prevention program includes tools and 10 collective workshops to change the life behaviours (eating habits and physical activity) by assessing : * food balance and diversity * eating behaviour and representations * level of knowledge in nutrition * level of physical activity and physical inactivity * physical abilities: strength, balance, flexibility, cardio respiratory endurance, recovery capacity * behavioural barriers and educational levers to improve women's cardiovascular health

Eligibility criteria:
inclusion criteria: * bmi \> 25kg/m² and/or with a waist circumference \> 88 cm * regularly consuming butter and/or "standard" margarine rich in saturated fatty acids exclusion criteria: * regularly consuming "healthy" margarine enriched with omega 3 (primevere, st hubert ω3 ...) or with phytosterols (pro-active) * consuming omega-3 rich food supplements within 3 months of inclusion * treated with lipid-lowering agents (statins), antidiabetic or antihypertensive drugs for less than 3 months * suffering of eating disorders * presenting a medical contraindication to the practice of physical activity * having previously participated in a similar prevention program * suffering from serious chronic diseases (cancer, serious cardiovascular history, etc.)

Keywords: nutritional and physical activity program prevention cardiovascular health quality of life
the effect of self-care education on self-care skills and school sociality

Conditions: Education; Intellectual Disabilities With Other Behavioral Symptoms

Summary: the aim of this study is to examine the effect of self-care education given to children with educable intellectual disabilities on children\&#39;s self-care skills and school social behaviors. h1a: there is a difference between the mean scores of the children in the experimental and control groups in the \&#34;eating skills\&#34; subscale of the self-care skills checklist according to time (pretest, posttest, 1st follow-up, 2nd follow-up). h1b: there is a difference between the mean scores of the children in the experimental and control groups on the \&#34;dressing skills\&#34; sub-dimension of the self-care skills checklist according to time (pretest, posttest, 1st follow-up, 2nd follow-up). h1c: there is a difference between the mean scores of the children in the experimental and control groups on the \&#34;personal care skills\&#34; sub-dimension of the self-care skills checklist according to time (pretest, posttest, 1st follow-up, 2nd follow-up). h1d: there is a difference between the mean scores of the children in the experimental and control groups on the \&#34;social competence\&#34; sub-dimension of the school social behavior assessment scale according to time (pretest, posttest, 1st follow-up, 2nd follow-up).

h1a: there is a difference between the mean scores of the children in the experimental and control groups in the \&#34;eating skills\&#34; subscale of the self-care skills checklist according to time (pretest, posttest, 1st follow-up, 2nd follow-up). h1b: there is a difference between the mean scores of the children in the experimental and control groups on the \&#34;dressing skills\&#34; sub-dimension of the self-care skills checklist according to time (pretest, posttest, 1st follow-up, 2nd follow-up). h1c: there is a difference between the mean scores of the children in the experimental and control groups on the \&#34;personal care skills\&#34; sub-dimension of the self-care skills checklist according to time (pretest, posttest, 1st follow-up, 2nd follow-up). h1d: there is a difference between the mean scores of the children in the experimental and control groups on the \&#34;social competence\&#34; sub-dimension of the school social behavior assessment scale according to time (pretest, posttest, 1st follow-up, 2nd follow-up).

Eligibility criteria:
inclusion criteria: * the child has mild and moderate intellectual disability (determined by the health reports available at the institution. children with mild and moderate intellectual disability were included in the study). * between the ages of 6 and 10 * volunteering to participate in the study and signing the informed consent form by the child's parent * following verbal instructions (determined by the reports given as a result of the evaluation conducted by the guidance and research center) exclusion criteria: * physical disability in addition to mental disability * getting sick or having an attack during work * illiteracy of parents

Keywords: child with intellectual disabilities self-care socialization
clinical study on the efficacy and safety of qingre heji in the treatment of acute upper respiratory tract infection

Conditions: Acute Upper Respiratory Tract Infection; Traditional Chinese Medicine; Randomised Controlled Trial

Summary: originating from china, tcm complements conventional approaches by alleviating symptoms, balancing physical conditions, and enhancing immunity. clinical studies have shown tcm to be safe and effective in treating auri. in tcm syndrome differentiation, auri is considered a "wind-heat syndrome", requiring treatment that clears heat and detoxifies the body. qing re he ji (qrhj; heat-clearing mixture), a tcm compound developed by our hospital, comprises huang qin (radix scutellariae), da qing ye (folium isatidis), ge gen (radix puerariae), yin chen (herba artemisiae scopariae), and guan zhong (cyrtomium rhizome). widely used for auri, qrhj effectively clears heat, eliminates pathogens, and strengthens healthy qi. clinical applications have demonstrated its efficacy, complemented by significant advancements in animal experiments and pharmacokinetics research. to further validate these results, systematic clinical research is imperative, especially in the context of limited direct comparisons between qrhj and other commercially available tcms like shuang huang lian (shl) oral liquid, known for its efficacy and safety in auri treatment. therefore, we performed a rigorously designed non-inferiority randomised controlled trial to assess the efficacy and safety of qrhj in treating auri in adults, comparing it directly with shl oral liquid. this study aimed to bridge existing research gaps and provide healthcare professionals with more diversified treatment options, thereby enhancing personalised and comprehensive patient care plans. furthermore, we hope that our findings will establish a scientific basis for integrating tcm into modern healthcare practices, promoting the synergy of chinese and western medicine.


Eligibility criteria:
inclusion criteria: * 1: voluntarily sign informed consent 2: age ≥ 18 years old 3: meet the diagnostic criteria of acute respiratory tract infection: internal medicine edited by chenhaozhu (9th edition, people's health publishing house) exclusion criteria: * 1: legal infectious diseases with upper respiratory symptoms 2: patients with severe pneumonia 3: severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system 4: after this episode, he has received other antiviral, anti-inflammatory, antipyretic and analgesic drugs or any other drugs to treat colds 5: pregnant or lactating women 6: allergic constitution and drug allergy 7: psychopath 8: those who have participated in other clinical trials within three months 9: persons with a history of drug abuse 10: other circumstances that the investigator believes are not suitable for enrollment
safety study providing 12 months follow-up from first exposure to hp802-247 in subjects with venous leg ulcer

Conditions: Venous Leg Ulcer

Summary: this observations safety study is intended for subject who participated in the 802-247-09-029 study with the investigational product hp802-247 for venous leg ulcers and received at least one application of hp802-247 or vehicle (an inactive substance). this study is being done for the following purposes: 1. to identify new adverse events, 2. to examine ongoing adverse events not resolved in subjects who participated in the 802-247-09-029 trial, 3. to record wound status, and 4. to determine if there are differences in health related quality of life (hrqol) associated with the treatment assignment from the 802-247-09-029 trial. investigational means that hp802-247 has not been approved by the u.s. food and drug administration (fda).


Eligibility criteria:
inclusion criteria: * provide informed consent document * subject was randomized in 802-247-09-029 and received at least one application of a test article. * subject has ended their participation in 802-247-09-029 by virtue of completing the study, or by dropping out prior to completion. exclusion criteria: * subjects who refuse to provide written informed consent will be excluded from this trial.

Keywords: venous leg ulcer ulcer venous stasis compression venous venous stasis ulcer vlu hp802-247-09-029